(91 days)
The ROTOCUT G1 Electromechanical Morcellator in conjunction with the UNIDRIVE GYN Control unit is a motorized unit for morcellating and extracting tissue during laparoscopic procedures in general surgery, gynecology including the removal of myomas and hysterectomy, and urology including nephrectomy.
The KSEA ROTOCUT G1 Electronechanical Morcellator in conjunction with the UNIDRIVE GYN control unit is a motorized, reusable surgical device system, intended for the morcellation and extracting tissue during laparoscopic procedures in general surgery, gynecology, and urology by qualified surgeons.
This document is a 510(k) summary for the KSEA ROTOCUT G1 Electromechanical Morcellator. It claims substantial equivalence to predicate devices and does not describe acceptance criteria, performance studies, or clinical trial data. Therefore, I cannot extract the requested information.
Here's why:
- 510(k) Substantial Equivalence: A 510(k) submission generally focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, indications for use, and performance characteristics, often through non-clinical testing (e.g., bench testing, biocompatibility).
- Lack of Clinical Study Details: The provided text is a summary of the 510(k) and the FDA's clearance letter. It does not contain details of specific clinical studies, performance criteria, sample sizes, expert qualifications, or ground truth establishment. The declaration of substantial equivalence usually implies that the performance is considered acceptable based on the predicate device's established safety and effectiveness.
To answer your request, I would need a different type of document, such as a full clinical study report, a regulatory submission with detailed performance data, or an FDA review memorandum that explicitly discusses clinical acceptance criteria and the results of a study designed to meet them.
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Image /page/0/Picture/0 description: The image shows a logo for Karl Storz Endoscopy. The logo is white and features the word "STORZ" in a stylized font. Below the word "STORZ" is the text "KARL STORZ ENDOSCOPY". The background of the image is black.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Page 1-21
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.600 Corporate Pointe DriveCulver City, CA 90230(310) 338-8100 | JUL 27 2006 |
|---|---|---|
| Contact: | James A. Lee, Ph.D.Senior Regulatory Affairs Specialist | |
| Device Identification: | Common Name:Tissue Morcellator | |
| Trade Name: (optional)KSEA ROTOCUT G1 Electromechanical Morcellator |
Indication: The ROTOCUT G1 Electromechanical Morcellator in conjunction with the UNIDRIVE GYN Control unit is a motorized unit for morcellating and extracting tissue during laparoscopic procedures in general surgery, gynecology including the removal of myomas and hysterectomy, and urology including nephrectomy.
Device Description: The KSEA ROTOCUT G1 Electronechanical Morcellator in conjunction with the UNIDRIVE GYN control unit is a motorized, reusable surgical device system, intended for the morcellation and extracting tissue during laparoscopic procedures in general surgery, gynecology, and urology by qualified surgeons.
Substantial Equivalence: The KSEA ROTOCUT GI Electromechanical Morcellator is substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA ROTOCUT G1 Electromechanical Morcellator and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.
Signed:
Jauffer
James A. Lee, Ph.D. Senior Regulatory Affairs Specialist
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 7 2006
Karl Storz Endoscopy % James A. Lee, Ph.D. Senior Regulatory Affairs Specialist 600 Corporate Pointe, 5th Floor Culver City, California 90230-7600
Re: K061180
Trade/Device Name: KSEA ROTOCUT G1 Electromechanical Morcellator and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ, HET Dated: June 29 2006 Received: June 30, 2006
Dear Dr. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to iegally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set
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Page 2 - James A. Lee, Ph.D.
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
C. Mark N. Melkerson
Mark N. Mel Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K061180
Device Name: KSEA ROTOCUT G1 Electromechanical Morcellator and Accessories
Indication for Use: The ROTOCUT G1 Electromechanical Morcellator in conjunction with the UNIDRIVE GYN Control unit is a motorized unit for morcellating and extracting tissue during laparoscopic procedures in general surgery, gynecology including the removal of myomas and hysterectomy, and urology including nephrectomy.
X PrescriptionUse: (Per 21 CFR 801 Subpart D) (Per 21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off Division of General, Restorative, and Neurological Devices
Kob1180 510(k) Numbe
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.